A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

NCT02850003 Phase 1 COMPLETED

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2016-06
Completion	2016-11

Conditions

• Acne

Interventions

• IDP-120 Gel

Primary outcomes

• Evaluators Global Severity Score At Day 15 — 15 Days
  Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).

Countries

United States